[Federal Register Volume 77, Number 188 (Thursday, September 27, 2012)]
[Notices]
[Pages 59403-59404]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-23779]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0190]


Determination That ENDURON (methyclothiazide) Tablets and Six 
Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety 
or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined that the 
seven drug products listed in this document were not withdrawn from 
sale for reasons of safety or effectiveness. This determination means 
that FDA will not begin procedures to withdraw approval of abbreviated 
new drug applications (ANDAs) that refer to these drug products, and it 
will allow FDA to continue to approve ANDAs that refer to the products 
as long as they meet relevant legal and regulatory requirements.

FOR FURTHER INFORMATION CONTACT: Mark Geanacopoulos, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6206, Silver Spring, MD 20993-0002, 301-
796-6925.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price 
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) 
(the 1984 amendments), which authorized the approval of duplicate 
versions of drug products approved under an ANDA procedure. ANDA 
sponsors must, with certain exceptions, show that the drug for which 
they are seeking approval contains the same active ingredient in the 
same strength and dosage form as the ``listed drug,'' which is a 
version of the drug that was previously approved. Sponsors of ANDAs do 
not have to repeat the extensive clinical testing otherwise necessary 
to gain approval of a new drug application (NDA). The only clinical 
data required in an ANDA are data to show that the drug that is the 
subject of the ANDA is bioequivalent to the listed drug.
    The 1984 amendments include what is now section 505(j)(7) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which 
requires FDA to publish a list of all approved drugs. FDA publishes 
this list as part of the ``Approved Drug Products With Therapeutic 
Equivalence Evaluations,'' which is generally known as the ``Orange 
Book.'' Under FDA regulations, drugs are withdrawn from the list if the 
Agency withdraws or suspends approval of the drug's NDA or ANDA for 
reasons of safety or effectiveness, or if FDA determines that the 
listed drug was withdrawn from sale for reasons of safety or 
effectiveness (21 CFR 314.162).
    Under 314.161(a) (21 CFR 314.161(a)), the Agency must determine 
whether a listed drug was withdrawn from sale for reasons of safety or 
effectiveness: (1) Before an ANDA that refers to that listed drug may 
be approved, (2) whenever a listed drug is voluntarily withdrawn from 
sale and ANDAs that refer to the listed drug have been approved, and 
(3) when a person petitions for such a determination under 21 CFR 
10.25(a) and 10.30. Section 314.161(d) provides that if FDA determines 
that a listed drug was removed from sale for safety or effectiveness 
reasons, the Agency will initiate proceedings that could result in the 
withdrawal of approval of the ANDAs that refer to the listed drug.
    As requested by the applicants, FDA withdrew approval of NDA 012524 
for Enduron (methyclothiazide) Tablets and NDA 017577 for Ditropan 
(oxybutynin chloride) Tablets in the Federal Register of March 19, 2012 
(77 FR 16039). In addition, FDA has become aware that

[[Page 59404]]

the other drug products listed in the table in this document are no 
longer being marketed.

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       Application No.                Drug                Applicant
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NDA 012524..................  ENDURON               Abbott Laboratories,
                               (methyclothiazide)    100 Abbott Park
                               Tablets, 2.5          Rd., Abbott Park,
                               milligrams (mg) and   IL 60064-3500.
                               5 mg.
NDA 016949..................  LIMBITROL and         Valeant
                               LIMBITROL DS          Pharmaceuticals
                               (amitriptyline        International,
                               hydrochloride;        Inc., 4787 Levy
                               chlordiazepoxide)     St., Montreal,
                               Tablets, equivalent   Quebec H4R 2P9,
                               to (EQ) 12.5 mg       Canada.
                               (base), 5 mg, and
                               EQ 25 mg (base), 10
                               mg.
NDA 017577..................  DITROPAN (oxybutynin  Janssen
                               chloride) Tablets,    Pharmaceuticals,
                               5 mg.                 Inc., 1125 Trenton-
                                                     Harbourton Rd.,
                                                     P.O. Box 200,
                                                     Titusville, NJ
                                                     08560.
NDA 017950..................  WESTCORT              Ranbaxy
                               (hydrocortisone       Laboratories, Ltd.,
                               valerate) Cream,      600 College Road
                               0.2%.                 East, suite 2100,
                                                     Princeton, NJ
                                                     08540.
NDA 018763..................  TOPICORT              Taro
                               (desoximetasone)      Pharmaceuticals,
                               Ointment, 0.25%.      Inc., 3 Skyline
                                                     Dr., Hawthorne, NY
                                                     10532.
NDA 020036..................  AREDIA (pamidronate   Novartis
                               disodium)             Pharmaceuticals
                               Injection, 30 mg/     Corporation, One
                               vial.                 Health Plaza, East
                                                     Hanover, NJ 07936-
                                                     1080.
NDA 020038..................  FLUDARA (fludarabine  Genzyme Corporation,
                               phosphate)            1850 K St. NW.,
                               Injection, 50 mg/     suite 650,
                               vial.                 Washington, DC
                                                     20006.
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    FDA has reviewed its records and, under 314.161, has determined 
that the drug products listed in this document were not withdrawn from 
sale for reasons of safety or effectiveness. Accordingly, the Agency 
will continue to list the drug products listed in this document in the 
``Discontinued Drug Product List'' section of the Orange Book. The 
``Discontinued Drug Product List'' identifies, among other items, drug 
products that have been discontinued from marketing for reasons other 
than safety or effectiveness.
    Approved ANDAs that refer to the NDAs listed in this document are 
unaffected by the discontinued marketing of the products subject to 
those NDAs. Additional ANDAs that refer to these products may also be 
approved by the Agency if they comply with relevant legal and 
regulatory requirements. If FDA determines that labeling for these drug 
products should be revised to meet current standards, the Agency will 
advise ANDA applicants to submit such labeling.

    Dated: September 24, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-23779 Filed 9-26-12; 8:45 am]
BILLING CODE 4160-01-P